Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease

Core Viewpoint - Genelux Corporation has received positive feedback from the U.S. FDA regarding the ongoing OnPrime/GOG-3076 Phase 3 trial for Olvi-Vec, which may support traditional approval for the treatment of platinum resistant/refractory ovarian cancer [1][4] Group 1: FDA Meeting and Trial Insights - The FDA meeting aimed to clarify the requirements for traditional approval of Olvi-Vec, focusing on the ongoing OnPrime/GOG-3076 trial [2] - The FDA indicated that an interim analysis of overall survival should be planned alongside the primary progression-free survival analysis, which could support traditional approval if a clinically meaningful PFS advantage is shown without a decrease in OS [3] - The FDA recommended that Genelux request a pre-BLA meeting to discuss topline safety and efficacy data after the trial's completion [3] Group 2: Trial Design and Patient Population - The OnPrime/GOG-3076 trial is a multi-center, randomized, open-label Phase 3 study evaluating Olvi-Vec in combination with platinum-doublet and bevacizumab against physician's choice of chemotherapy and bevacizumab in patients with PRROC [5] - The trial includes patients who are platinum resistant/refractory and have undergone at least three prior lines of therapy, with no cap on previous treatments [6] - The trial aims to enroll enough patients to achieve 127 events, with primary and secondary endpoints focusing on progression-free survival and overall survival, respectively [5] Group 3: Olvi-Vec Overview - Olvi-Vec is a proprietary modified oncolytic vaccinia virus developed by Genelux for treating various cancers, showing potential to infect and kill tumor cells while eliciting an anti-tumor immune response [7] - The drug has been administered to over 150 patients in previous clinical trials, demonstrating good tolerability and clinical benefits [7] - Olvi-Vec has received Fast Track designation from the FDA for treating platinum resistant/refractory ovarian cancer [7] Group 4: Company Background - Genelux Corporation is a late-stage clinical biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [8] - In addition to the OnPrime/GOG-3076 trial, Olvi-Vec is being evaluated in two other clinical studies targeting platinum resensitization in non-small-cell lung cancer and small cell lung cancer [9]